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Trial record 51 of 235 for:    PRASTERONE

7-Keto DHEA for the Treatment of PTSD

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ClinicalTrials.gov Identifier: NCT01861847
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Humanetics Corporation

Brief Summary:
The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing symptoms of Post-Traumatic Stress Disorder (PTSD).

Condition or disease Intervention/treatment Phase
PTSD Drug: 7-Keto Dehydroepiandrosterone Drug: Placebo Phase 2

Detailed Description:
The main purpose of the study is to investigate the possible effect of 7-Keto Dehydroepiandrosterone (7-Keto DHEA) on decreasing Post Traumatic Stress Disorder Symptoms (PTSD) in a Veteran population. The study proposes, based on a 2006 report, that the use of the drug will show significant reduction in overall PTSD symptoms, a decrease in physiological stress response and higher patient-reported quality of life compared to placebo. This is a Phase 2, randomized, double-blind, crossover design with a placebo control. The sponsor for this study is Humanetics Corporation

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 7-Keto DHEA for the Treatment of PTSD
Study Start Date : February 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Placebo Comparator: Placebo Group
Placebo Comparator
Drug: Placebo
Placebo, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.

Active Comparator: Drug group
7 Keto-DHEA
Drug: 7-Keto Dehydroepiandrosterone
7-Keto Dehydroepiandrosterone, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.
Other Name: 7-Keto DHEA




Primary Outcome Measures :
  1. Psychological benefits of 7-Keto DHEA (Dehydroepiandrosterone) in Veterans suffering from PTSD participating in the intervention through questionnaires and corresponding measurement of blood work for amounts of DHEA. [ Time Frame: Four months ]

    Outcome measures include analysis in symptoms of depression, anxiety, stress, trauma, and improved memory and cognitive functioning after treatment with 7-Keto DHEA. Measures will include psychological questionnaires as follows:

    PTSD Checklist (PCL-C) Associated Symptoms of PTSD Scale (ASP) Trauma Symptom Inventory (TSI) Dissociative Experience Scale (DES) Beck Depression Inventory - II (BDI-II) Brief Symptom Inventory (BSI) Quality of Life Inventory (QOLI)


  2. Physiological benefits of 7-Keto DHEA (Dehydroepiandrosterone) in Veterans suffering from PTSD participating in the intervention through questionnaires and corresponding measurement of blood work for amounts of DHEA. [ Time Frame: Four months ]
    DHEA (DHEA-S) concentrations (serum, saliva) are often elevated in men and women suffering from PTSD including that related to combat experience. Several studies have shown an association between higher levels of DHEA/DHEA-S and abatement of PTSD symptoms. Outcome measures include analysis of medical assessments via blood work; Complete Blood Count (CBC), Cortisol, and DHEA sulfate level



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veteran status and enrolled for care in the Veteran Health Administration
  • Ages 18-64
  • Primary diagnosis of PTSD as assess by the clinician administered PTSD scale and independent clinical mental health evaluation

Exclusion Criteria:

  • psychosis
  • Dementia
  • Active alcohol and/or substance abuse or dependence
  • Active suicidal or homicidal ideation
  • Medical concerns that would exclude use of 7-Keto DHEA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861847


Locations
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United States, Florida
Bay Pines VA Healthcare System
Bay Pines, Florida, United States, 33744
Sponsors and Collaborators
Humanetics Corporation
Investigators
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Principal Investigator: Alina Gonzalez-Mayo, MD Bay Pines VAHCS

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Responsible Party: Humanetics Corporation
ClinicalTrials.gov Identifier: NCT01861847     History of Changes
Other Study ID Numbers: 2905
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs